Imaging Study in Metastatic UC, HR+ and HER2- Breast Cancer, TNBC, and NSCLC

NCT07671092 | Not Yet Recruiting Early Phase 1

• 1 other identifier: RYZ211-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This imaging study aims to assess the feasibility, biodistribution, and dosimetry of the imaging agent in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC.

Conditions

Metastatic Urothelial Carcinoma; Breast Cancer; TNBC - Triple-Negative Breast Cancer; Hormone Receptor Positive HER-2 Negative Breast Cancer; NSCLC

Keywords

HR+; HER2-; Breast Cancer; Non Small Cell Lung Cancer; Triple Negative Breast Cancer; TNBC; RayzeBio; Rayze; BMS; Bristol Myers Squibb; RPT; Imaging Agent

Outcome Measures

Primary Outcomes (2)

• To evaluate the biodistribution of RYZ211 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

  To evaluate the biodistribution of RYZ211 using SUV (mean, maximum, and peak) of critical organs (blood pool, salivary glands, thyroid, pancreas, liver, kidney \[cortex\], bone) and tumors; tumor-to-normal organ tracer uptake ratios in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

  Study duration (1 year)

• To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 in subjects with metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

  To evaluate the long biodistribution and radiation absorbed doses in critical organs and tumors, and the effective dose of RYZ212 by using calculated mean TIAC (MBq · h/MBq), radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to critical organs (salivary glands, thyroid, pancreas, liver, kidneys, bone marrow), calculated mean TIAC (MBq · h/MBq) and radiation absorbed dose coefficients (mGy/MBq) and absorbed dose (Gy) to tumors, calculated whole-body effective dose (mSv/MBq)

  Study duration (1 year)

Study Arms (1)

RYZ211/212

EXPERIMENTAL

Diagnostic Test: RYZ211/212

Interventions

RYZ211/212 DIAGNOSTIC_TEST

Imaging Agent

RYZ211/212

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are at least 18 years old at the time of signing the informed consent form (ICF)
• Have biopsy proven metastatic UC, HR+ and HER2- breast cancer, TNBC, or NSCLC

You may not qualify if:

• For Women of Childbearing Potential: Are pregnant or breastfeeding
• Note: Additional criteria may apply and will be assessed by the study site

Sponsors & Collaborators

• RayzeBio, Inc.: lead

Study Sites (1)

Research Facility

Christchurch, New Zealand

Location

MeSH Terms

Conditions

Carcinoma, Transitional Cell; Breast Neoplasms; Triple Negative Breast Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Freddy Escorcia

  RayzeBio, Inc.

  STUDY DIRECTOR

• Heying Duan

  RayzeBio, Inc.

  STUDY DIRECTOR

Central Study Contacts

RayzeBio Clinical Trials

CONTACT

(619) 657-0057; clinicaltrials@rayzebio.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: June 26, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Locations

NZ (1)